EP3821869A1 - Unité de capteur pour une thérapie par compression comprenant un capteur de pression et un capteur d'oxygène de mesure par oxymétrie de pouls - Google Patents
Unité de capteur pour une thérapie par compression comprenant un capteur de pression et un capteur d'oxygène de mesure par oxymétrie de pouls Download PDFInfo
- Publication number
- EP3821869A1 EP3821869A1 EP20208059.4A EP20208059A EP3821869A1 EP 3821869 A1 EP3821869 A1 EP 3821869A1 EP 20208059 A EP20208059 A EP 20208059A EP 3821869 A1 EP3821869 A1 EP 3821869A1
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- European Patent Office
- Prior art keywords
- sensor
- mmhg
- oxygen
- sensor unit
- pressure
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- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 title claims abstract description 195
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Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
- A61H9/00—Pneumatic or hydraulic massage
- A61H9/005—Pneumatic massage
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- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0048—Detecting, measuring or recording by applying mechanical forces or stimuli
- A61B5/0053—Detecting, measuring or recording by applying mechanical forces or stimuli by applying pressure, e.g. compression, indentation, palpation, grasping, gauging
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- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
- A61B5/026—Measuring blood flow
- A61B5/0261—Measuring blood flow using optical means, e.g. infrared light
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- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
- A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
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- A61B5/6843—Monitoring or controlling sensor contact pressure
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- A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
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- A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
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- A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
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- A61H2209/00—Devices for avoiding blood stagnation, e.g. Deep Vein Thrombosis [DVT] devices
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- A61H2230/00—Measuring physical parameters of the user
- A61H2230/20—Blood composition characteristics
- A61H2230/207—Blood composition characteristics partial O2-value
- A61H2230/208—Blood composition characteristics partial O2-value used as a control parameter for the apparatus
Definitions
- the invention relates to a sensor unit for compression therapy as well as a kit, a compression means and a compression therapy system comprising the sensor unit.
- the invention also relates to a manufacturing method for the sensor unit and a use of the sensor unit for compression therapy.
- Compression bandages for the treatment of venous insufficiency are known. To treat venous insufficiency, the compression bandages must neither be applied with too low nor too high a pressure. If the application pressure is too low, the treatment may not have any effect. If the contact pressure is too high, the treated parts of the body may no longer be properly supplied with blood and may be damaged. In order to set the correct application pressure, compression bandages with mechanical pressure indicators and with electronic pressure sensors are known.
- the control of the application pressure is not sufficient in all cases to ensure uncomplicated treatment of venous insufficiency.
- the sole control of the application pressure may not be sufficient in patients who have both venous insufficiency and arterial occlusive disease (AVC).
- AVC arterial occlusive disease
- normally unproblematic application pressure can lead to reduced perfusion of the affected extremity and, as a result, to tissue destruction.
- compression therapy is often not used in these patients for safety reasons and their venous insufficiency is left untreated, although compression therapy might be possible and lead to an improved blood supply by reducing venous hypertension and thus to an increase in the pressure difference between the blood pressure in the arterial and venous compartments could.
- the present invention was based on the object of improving the safety of compression therapy. This object is achieved with a sensor unit according to claim 1 and a manufacturing method according to claim 23.
- the sensor unit for compression therapy comprises a substrate, a pressure sensor and a pulse oximetric oxygen sensor.
- the pressure sensor and the oxygen sensor are arranged on the substrate. Furthermore, measured values of the pressure sensor and the oxygen sensor can be transmitted to a computer for checking the compression therapy.
- the sensor unit When used in compression therapy, the sensor unit according to the invention makes it possible, on the one hand, to monitor the pressure acting on the treated part of the patient's body. In addition, the sensor unit makes it possible to monitor the oxygen saturation of the arterial blood in the treated part of the patient's body.
- the first measure - pressure monitoring - in particular an acute failure of the compression therapy when the pressure is too low or an acute danger situation as a result of the compression therapy when the pressure is too high can be detected.
- the second measure - the monitoring of the oxygen saturation - is used in particular to detect a lack of blood flow in the treated part of the body as a result of excessive compression for the patient.
- Another advantage of the present invention is that the pressure sensor and the oxygen sensor form a unit. This improves the handling of the sensors and both the pressure and the oxygen saturation can be measured at the same part of the body. Further advantages of the invention emerge from the preferred embodiments described below.
- the substrate of the sensor unit can be a printed circuit board, in particular a flexible printed circuit board.
- the attachment of the sensor unit to the patient's body or to a compression means can be made easier if the circuit board is flexible.
- the flexible printed circuit board also improves the comfort of the sensor unit in particular.
- the flexible printed circuit board is preferably a polymer film on which electronic components are applied, in particular printed.
- the pressure sensor can be a strain gauge, an inductive pressure sensor or a piezoelectric pressure sensor.
- the piezoelectric pressure sensor is preferred from this group.
- the oxygen sensor includes a red light source, an infrared light source, and a photodetector.
- the light sources are preferably light-emitting diodes (LED).
- the photodetector is preferably a photodiode.
- Such an oxygen sensor is sold under the name BIOFY® SFH7060 by Osram Opto Semiconductors (Regensburg, Germany).
- the light sources can be used to generate light of the wavelengths 660 nm (red light) and 940 nm (infrared light).
- the photodetector can detect the light passing through the tissue or reflected by the tissue, whereupon the oxygen saturation of the arterial blood can be calculated by the computer using methods known per se in the prior art.
- the measured value of the oxygen sensor according to the claims can comprise measured values of the photodetector with regard to the transmitted or reflected red light as well as measured values of the photodetector with regard to the transmitted or reflected infrared light.
- the oxygen sensor is preferably a reflection pulse oximetric oxygen sensor.
- the pulse oximetric oxygen sensor preferably uses the principle of reflection oximetry. This significantly simplifies the arrangement of the oxygen sensor on the patient's body.
- the above-mentioned components of the oxygen sensor (light sources and detector) then do not have to be arranged at opposite body parts as in the case of alternative transmission oximetry, but can be placed at the same body part. From a technical point of view, the sensor unit provided according to the invention could only be implemented with difficulty with a transmission pulse oximetric oxygen sensor, so that this variant is less preferred.
- the computer is preferably a mobile device.
- a smartphone or a tablet, in particular, can be considered as the mobile device for the invention.
- the number of electronic components on the sensor unit can be minimized because an existing, high-performance device belonging to the patient or the nursing staff can be used for data evaluation and data display.
- the handling and the wearing comfort of a compression therapy system comprising the sensor unit can be improved in this way.
- the measured values of the pressure sensor and the oxygen sensor are transmitted to the computer in a wired manner.
- the transmission preferably via near field communication (NFC), Bluetooth or a wireless local area network (WLAN) ) takes place.
- NFC near field communication
- WLAN wireless local area network
- the measured values can be transferred to any location and the handling and wearing comfort of the sensor unit can be improved.
- the sensor unit can comprise an NFC transceiver, a Bluetooth transceiver and / or a WLAN transceiver.
- the computer then typically also comprises such an NFC transceiver, Bluetooth transceiver and / or WLAN transceiver.
- the measured values of the pressure sensor and the oxygen sensor be transmitted to the computer in encrypted form.
- the encryption can be carried out, for example, by a data acquisition unit comprised by the sensor unit.
- the decryption of the measured values can be carried out by the computer.
- the already mentioned data acquisition unit is primarily designed to acquire the measured values from the pressure sensor and the oxygen sensor and to transmit them to the computer.
- the data acquisition unit can be arranged on the substrate of the sensor unit. However, it can also be connected to the substrate of the sensor unit with a connector, for example a cable.
- the data acquisition unit can comprise a data carrier and the transceiver of the sensor unit (NFC, Bluetooth and / or WLAN transceiver).
- the data acquisition unit can comprise a microcontroller, a preamplifier and an analog-digital converter.
- the data acquisition unit can also represent a computer in itself.
- the sensor unit comprises an energy source, preferably a battery, for the pressure sensor and the oxygen sensor.
- the energy source enables permanent activation of the sensors, i.e. continuous monitoring of the pressure and oxygen conditions.
- the energy source can be arranged on the substrate of the sensor unit.
- the sensor unit does not include an energy source for the pressure sensor and the oxygen sensor.
- the sensor unit can be simplified and its wearing comfort can be increased.
- the sensors can be supplied with energy by means of NFC radio signals from the smartphone used, for example.
- the sensor unit is designed to be adhesive.
- the sensor unit preferably comprises an adhesive backing layer, in which case the sensor unit can then be designed in the manner of a plaster.
- This embodiment has the particular advantage that the sensor unit can be attached to the patient's body easily and without additional aids (such as an adhesive plaster, for example).
- the present invention also relates to a kit for compression therapy.
- the kit comprises a compression means, one or more sensor units according to the invention in all their embodiments, optionally one or more adhesive plasters and optionally instructions for use.
- the adhesive plaster is provided for fastening the sensor unit to the patient's body and is advantageously included in the kit if the sensor unit is not designed to be adhesive.
- the sensor unit can also be provided connected to a compression means by the manufacturer.
- a compression means comprising one or more sensor units according to the invention in all of their embodiments is also claimed in the present case.
- the sensor unit is attached to the patient's body at the same time as the compression means is applied. There is therefore no need for a work step for the user (namely the separate attachment of the sensor unit to the measuring point), which can accelerate and simplify the preparation of the compression therapy.
- the user is then no longer completely free in his choice of where the sensor unit should be placed to collect the measured values, since the manufacturer's integration of the sensor unit into the compression means automatically results in a certain sensor arrangement on the patient's body.
- An integration of the Sensor unit in the compression means is nevertheless particularly useful when a strain gauge is used as the pressure sensor.
- the above method for checking the compression therapy provides a specific possibility of how the measurement data recorded by the sensor unit can be evaluated effectively and in the sense of a safe compression therapy.
- the aforementioned means of the computer are in particular a processor and a computer program.
- the measured values of the pressure sensor and in particular of the oxygen sensor may be necessary so that the comparison with the reference ranges and limit values mentioned in the present document can take place.
- Such further processing of the measured values can be carried out by the computer as part of the corresponding tests.
- the sensor unit (for example its data acquisition unit) supports the computer of the compression therapy system in checking the measured values of the pressure sensor and the oxygen sensor.
- the sensor unit could carry out the further processing of the measured values of the pressure sensor and the oxygen sensor just described.
- the compression means mentioned several times before can be a compression bandage, a compression tube or a compression stocking.
- the compression bandage has the advantage that it can be applied to different parts of the body.
- the compression hose and the compression stocking can be put on quickly and easily.
- Compression bandages are commercially available, for example from the patent applicant Paul Hartmann AG (Heidenheim, Germany) under the brand name Pütter®.
- a compression bandage can be used in combination with a compression stocking.
- the compression therapy system comprises several sensor units and thus also several pressure and oxygen sensors. This allows the pressure and oxygen saturation to be determined at various points under the compression medium. The accuracy of the system is increased.
- the compression therapy system according to this preferred embodiment comprises a plurality of pressure sensors and a plurality of pulse oximetric oxygen sensors, each of the additional sensors, insofar as this is not already explicitly provided, can also be part of the embodiments described below.
- a pressure sensor or an oxygen sensor is spoken of in an embodiment of the compression therapy system mentioned below, a plurality of pressure sensors or a plurality of oxygen sensors can also be meant when this subsequent embodiment is combined with the present embodiment.
- a measured value can be received from each pressure and oxygen sensor and checked separately.
- the measuring points with the sensor units can be monitored individually with regard to pressure and oxygen saturation, which is considered to be particularly advantageous in the present case.
- the measured values of the pressure sensor and the oxygen sensor are received and checked immediately after the measured values have been recorded by the sensors. This allows the user of the system to be informed of the current status of the compression therapy. It is also preferred that the receiving and checking of the measured value of the pressure sensor and the receiving and checking of the measured value of the oxygen sensor take place at the same time. As a result, the user of the system can be fully informed about the status of the compression therapy.
- the measured values of the pressure sensor and the oxygen sensor can be received and checked automatically and continuously after the start of the compression therapy or at least automatically at regular intervals after the start of the compression therapy. The check of the measured values can then not be forgotten, which increases the security of the system.
- the measured values of the pressure sensor and the oxygen sensor can be received and checked exclusively at the command of a user. This can simplify the system because, for example, an energy source for the sensors on the sensor unit can then be dispensed with.
- the pressure range used by the computer to check the pressure measured value has a lower limit and an upper limit.
- the lower limit of the pressure range can have a value of 1 mmHg to 20 mmHg, preferably 10 mmHg to 20 mmHg and particularly preferably 15 mmHg to 20 mmHg.
- the upper limit of the pressure range can have a value of 40 mmHg to 200 mmHg, preferably 40 mmHg to 120 mmHg, more preferably 40 mmHg to 100 mmHg, even more preferably 40 mmHg to 80 mmHg and particularly preferably 40 mmHg to 60 mmHg.
- the lower limit has a value of 20 mmHg and the upper limit has a value of 40 mmHg, so that a pressure range of 20 mmHg to 40 mmHg results.
- An alarm would then output if the measured pressure is outside the pressure range of 20 mmHg to 40 mmHg.
- Both a measurement pressure below 20 mmHg and a measurement pressure above 40 mmHg would be viewed as lying outside the pressure range. In the case of a measured pressure within the aforementioned pressure range, that is to say with a measured pressure of 20 mmHg to 40 mmHg, however, no alarm message would be issued.
- the oxygen saturation determined by pulse oximetry is usually a percentage value. This indicates what percentage of the red blood pigment hemoglobin is loaded with oxygen. Values above 95% can be regarded as harmless and within the normal range.
- the lower limit for the oxygen saturation can be selected from a range from 95% to 70%, preferably 90% to 70%.
- the lower limit for oxygen saturation can be 95%, 90%, 85%, 80%, 75% or 70%.
- the lower limit for the oxygen saturation is 90% or 85%.
- a patient-related value is used for the lower limit of the oxygen saturation.
- the lower limit for the oxygen saturation is an oxygen saturation of the body part to be treated or treated, which is measured by the oxygen sensor before the start or at the start of the compression therapy. This allows the patient's constitution to be taken into account when monitoring compression therapy.
- the computer can advantageously further comprise means for executing a method for checking a pulse rate.
- the computer receives a measured value from the oxygen sensor during the compression therapy and checks it to determine whether it is outside a specified pulse range. An alarm is preferably output if the test shows that the measured value of the oxygen sensor is outside the specified pulse range.
- the measured value used here can be the same measured value that is used to check the compression therapy.
- the pulse rate can provide information about the circulatory status of the patient being treated and can also be of interest to the user of the compression therapy system.
- the oxygen sensor also includes a light source for green light, in particular a green LED.
- a measured value can be received from each oxygen sensor in the method for checking the pulse rate, the measured values of the oxygen sensors being combined to form a single, combined oxygen sensor measured value.
- the combined oxygen sensor reading is then checked to determine whether it is outside the specified pulse range.
- the alarm is preferably output when the test shows that the combined oxygen sensor measured value is outside the specified pulse range.
- the combined oxygen sensor measured value is preferably an average value.
- the pulse range also has a lower limit and an upper limit.
- the lower limit of the pulse range can have a value of 40 beats / min to 60 beats / min, in particular 50 beats / min.
- the upper limit of the pulse range can have a value of 100 beats / min to 200 beats / min, in particular 150 beats / min.
- a pulse range of 50 beats / min to 150 beats / min is therefore preferred.
- alarms are provided in the event that the measured values do not correspond to the specified reference ranges and limit values. It can be useful to delay the output of the alarms until the result of the tests has been confirmed once or several times. False alarm messages as a result of only brief or temporary changes in pressure, oxygen saturation or pulse rate can thus be avoided.
- the alarm delay proposed in this way is based in particular on the aforementioned embodiment, in which the measured values of the pressure sensor are received and checked and the oxygen sensor takes place automatically and continuously or at least automatically at regular intervals after the start of the compression therapy.
- the alarms are typically output visually and / or acoustically.
- the computer usually comprises an input device and an output device.
- the input means can serve to receive commands or specifications from the user.
- the output means can serve to display the measured pressure, oxygen saturation and pulse rate values and to output the alarms.
- a touch screen of, for example, a smartphone or tablet can function as both input means and output means.
- the output means can also be a loudspeaker (acoustic alarms). Every smartphone or tablet these days has a touch screen and a speaker.
- the data carrier can be used to store computer programs and the measured values received. This enables the user to retrace the entire course of the compression therapy with all the measured values received.
- the data carrier can be a hard disk, a semiconductor drive (solid-state drive, SSD) or an SD card (secure digital memory card). It is also conceivable that the sensor measured values from the computer of the compression therapy system are stored in an online-based data storage service (cloud) or on a local network drive.
- the manufacturing method can also contain features of the previously described embodiments of the sensor unit according to the invention.
- a sensor unit according to the invention in all of its embodiments for checking a compression therapy of a person or Animal placed under protection.
- compression therapy is used to treat a human lower leg.
- the invention is also directed to the kit according to the invention, the compression means according to the invention (with the sensor unit) and the system according to the invention in all their embodiments for use in the treatment of venous insufficiency.
- This is intended to be based on a medical indication of the cited objects according to the invention.
- the treatment is intended in particular for patients at risk, for example a patient with venous insufficiency and arterial occlusive disease.
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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DE102019131056.3A DE102019131056A1 (de) | 2019-11-18 | 2019-11-18 | Sensoreinheit für eine Kompressionstherapie umfassend einen Drucksensor und einen pulsoximetrischen Sauerstoffsensor |
Publications (1)
Publication Number | Publication Date |
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EP3821869A1 true EP3821869A1 (fr) | 2021-05-19 |
Family
ID=73455603
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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EP20208059.4A Pending EP3821869A1 (fr) | 2019-11-18 | 2020-11-17 | Unité de capteur pour une thérapie par compression comprenant un capteur de pression et un capteur d'oxygène de mesure par oxymétrie de pouls |
Country Status (2)
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EP (1) | EP3821869A1 (fr) |
DE (1) | DE102019131056A1 (fr) |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
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WO2019072531A1 (fr) * | 2017-09-28 | 2019-04-18 | Smith & Nephew Plc | Neurostimulation et surveillance à l'aide d'un appareil de surveillance et de traitement de plaie activé par un capteur |
US20190254906A1 (en) * | 2016-04-27 | 2019-08-22 | Radial Medical, Inc. | Adaptive compression therapy systems and methods |
WO2020049291A1 (fr) * | 2018-09-05 | 2020-03-12 | The University Of Nottingham | Surveillance de paramètres physiologiques |
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CN102176857B (zh) * | 2008-09-01 | 2015-04-01 | 爱康医学农业合作协会有限公司 | 无线医学监测系统 |
WO2015168720A1 (fr) * | 2014-05-07 | 2015-11-12 | University Of South Australia | Capteur de plaie, système et procédé |
EP3240471A4 (fr) * | 2014-11-05 | 2018-10-03 | The Regents of the University of California | Système de détection portable de télémédecine pour la gestion de troubles veineux chroniques |
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US20190254906A1 (en) * | 2016-04-27 | 2019-08-22 | Radial Medical, Inc. | Adaptive compression therapy systems and methods |
WO2019072531A1 (fr) * | 2017-09-28 | 2019-04-18 | Smith & Nephew Plc | Neurostimulation et surveillance à l'aide d'un appareil de surveillance et de traitement de plaie activé par un capteur |
WO2020049291A1 (fr) * | 2018-09-05 | 2020-03-12 | The University Of Nottingham | Surveillance de paramètres physiologiques |
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